UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040191
Receipt No. R000045763
Scientific Title Indications for lower limb orthoses in stroke patients
Date of disclosure of the study information 2020/04/18
Last modified on 2021/04/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Indications for lower limb orthoses in stroke patients
Acronym indication of KAFO
Scientific Title Indications for lower limb orthoses in stroke patients
Scientific Title:Acronym indication of KAFO
Region
Japan

Condition
Condition cerebral infarction
cerebral hemorrhage
subarachnoid hemorrhage
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the validity of using KAFO early after the onset of stroke by examining lower limb muscle tone, pain and daily activities.
By clarifying the effects of the use of lower limb orthoses on the physical activity of stroke patients early after the onset of stroke, if the advantages and disadvantages of using lower limb orthoses become clear, determine the timing of preparation and duration of use It will be an indicator.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Modified Tardieu scale(MTS)
muscle tone examination
Key secondary outcomes evaluation of pain
SIAS
Fugl-Meyer assessment
Functional Independence measure : FIM

1 time every 2 weeks
Until discharge

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Standing training and gait training during physical therapy with long leg brace.
Interventions/Control_2 Standing training and walking training during physical therapy without wearing long leg brace.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1.First stroke patient (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage) who was admitted to Onishi Neurosurgery Hospital and was prescribed physiotherapy
2.The wearing time is decided based on the wearing adaptation table
3.Consciousness disorder JCS single digit or less
4.Understand verbal instructions
5.Sitting is possible (may be assisted)
6.Non-paretic side lower limb muscle strength MMT4 or higher
Key exclusion criteria If you have a history of diabetes mellitus or spinal cord / spinal cord disease
Target sample size 70

Research contact person
Name of lead principal investigator
1st name nobuhiko
Middle name
Last name iwai
Organization kobe gakuin university
Division name Faculty of Rehabilitation
Zip code 652-2180
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe-shi
TEL 078-974-1551
Email iwai@reha.kobegakuin.ac.jp

Public contact
Name of contact person
1st name takahiro
Middle name
Last name yoshino
Organization ohnishi neurological center
Division name department of rehabilitation
Zip code 674-0064
Address 1661-1 eigashima,okubo-tyou,akashi city
TEL 078-938-1257
Homepage URL
Email y-takahiro310@msn.com

Sponsor
Institute kobe gakuin university
Institute
Department

Funding Source
Organization kobe gakuin university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization kobe gakuin university
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe-shi
Tel 078-974-4297
Email kenkyu@j.kobegakuin.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 医療法人社団英明会、大西脳神経外科病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2020 Year 05 Month 01 Day
Date of IRB
2019 Year 08 Month 08 Day
Anticipated trial start date
2020 Year 05 Month 11 Day
Last follow-up date
2022 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 18 Day
Last modified on
2021 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045763

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.